Abilify (aripiprazole) treats psychological conditions, including schizophrenia and mania. But for some, the medication causes other psychological problems. This can ruin lives.
Hundreds of people have filed lawsuits saying Abilify caused them to compulsively gamble, spend money or eat.
Other compulsive-behavior side effects covered in the lawsuits include suicide attempts and thoughts, as well as compulsively viewing pornography and playing video games.
Abilify lawsuits also blame the drug for tardive dyskinesia. This condition causes involuntary movements.
Judge Demands Settlement Plan
As of September 2018, a total of 1,675 Abilify lawsuits were pending in a federal court in north Florida.
Chief U.S. District Judge M. Casey Rodgers ordered the parties to finalize a framework for a global settlement by Sept. 1, 2018.
But the deadline passed without an announcement from either side. At the same time, the court forward with plans for bellwether trials.
The court selected six cases for trial in the spring of 2019. Specific trial dates have not been set.
- Bruce Bletz of California
- Licente Harned of Pennsylvania
- Christine M. Kennedy of Massachusetts
- Annette Northcutt of Nevada
- Louis M. Ortiz of Arizona
- Valerie D. Stingley of Arizona
Lawsuits in U.S., Canada
Bristol-Myers Squibb Company and Otsuka Pharmaceutical Co. are the two companies responsible for Abilify. Bristol-Myers Squibb says in U.S. Securities and Exchange Commission filings that the companies are facing Abilify lawsuits in various state courts, as well as in Canada.
In May 2018, the New Jersey Supreme Court agreed to consolidate 42 Abilify lawsuits into multicounty litigation.
In August 2018, 17 plaintiffs filed lawsuits in the Philadelphia Court of Common Pleas. Lawsuits claim Abilify caused compulsive gambling, shopping, sex and binge eating.
Hundreds of Canadians filed an Abilify class action lawsuit in 2017. Among the plaintiffs was Christina Milisic, who said she lost upwards of $400,000 from the compulsive gambling habit she developed while taking the drug.
People are seeking to recover expenses they incurred after they claim Abilify caused them to engage in compulsive behaviors.
For example, compulsive gamblers filed lawsuits seeking reimbursement for their losses. Compulsive eaters want money for medical costs, including weight-loss surgery. People who engaged in hypersexual activity want compensation for their financial and emotional costs from a divorce, for example.
Lawsuits say Abilify labels in Europe and Canada warned about the risk of “pathological gambling,” while these warnings were not included on labels in the U.S. before January 2016.
At that time, pathological gambling was included in the “postmarketing experience” portion of the U.S. labels, but not in the warning portion.
Compulsive behavior warnings were added to U.S. labels in August 2016. This followed the FDA’s May 3, 2016 announcement that the warnings should be added.
Abilify Users Reveal Struggles
Within seven months of the FDA’s announcement, more than 40 Abilify lawsuits were filed.
Plaintiffs who filed lawsuits against Bristol-Myers Squibb and Otsuka said the drug turned them into compulsive gamblers and sex addicts.
- Joseph Edgar
- In April 2016, Joseph Edgar filed suit, alleging that he began to gamble compulsively after he began taking Abilify in April 2009. The gambling problems stopped after he stopped taking the drug in April 2014, but he had lost more than $36,000 and faced other mental and physical damages.
- Athalean Harper-Mosley
- A day after Edgar filed suit in Pennsylvania, a woman named Athalean Harper-Mosley filed a similar suit in California. She claims she began taking Abilify in July 2007, incurred gambling losses of more than $65,000 and stopped having impulsivity problems after she stopped taking the drug in May 2014.
- Patrick Parks
- Patrick Parks sued the drug’s makers in November 2016. Parks began taking the drug around May 2013 and “began compulsively gambling shortly thereafter,” his complaint says. He stopped taking Abilify in August 2014 and stopped gambling. But by then he had already lost more than $75,000.
- Rikki Carlson
- Similarly, Massachusetts resident Rikki Carlson sued Bristol-Meyers Squibb, Otsuka Pharmaceutical and Otsuka American Pharmaceutical alleging that after she began taking Abilify in December 2010, she began compulsively gambling, eating and shopping. Those behaviors stopped after she stopped taking the medication in March 2016.
On July 5, 2018, a federal judge in West Virginia ruled against a man who sued Bristol-Myers Squibb. That lawsuit said Donald W. Proffitt Jr. developed tardive dyskinesia as a result of taking Abilify.
Tardive dyskinesia is a condition of the nervous system in which the sufferer is afflicted with involuntary movements. It typically involves facial tics, jaw clenching and clucking, and eye blinking.
Senior U.S. District Judge David A. Faber noted in his opinion that Abilify labels carried detailed warnings about tardive dyskinesia.
Type 2 Diabetes Claims Dismissed
Five women sued Bristol-Myers Squibb Co. and Otsuka American Pharmaceutical in 2014 and 2015, alleging Abilify caused Type 2 diabetes in children. The companies failed to warn physicians who prescribed the drug for off-label use of that risk, their lawsuits say. Those suits were dismissed. They were all filed in New York, and the defendants successfully argued that they would be unable to get out-of-state witnesses to testify.
Kickback Allegations Tossed
A U.S. judge tossed federal-court claims that Bristol-Myers Squibb and Otsuka Pharmaceutical paid kickbacks to persuade doctors to prescribe Abilify. Two whistleblowers brought the lawsuit in 2011, pointing to promotions to pediatric psychiatrists as evidence of off-label marketing. Judge William Bertelsman said in his ruling that there was a lack of specific evidence to support the kickback claims. He did, however, permit the whistleblowers to pursue claims that Bristol-Myers fired them to retaliate for their off-label accusations.
Federal, State Settlements
It is not illegal for doctors to prescribe a medication for an unapproved use, but it is illegal for drug companies to encourage doctors to do it. Bristol-Myers Squibb has paid two, multimillion-dollar settlements to resolve allegations that it did just that.
In 2007, Bristol-Myers Squibb paid more than $515 million to settle allegations that it illegally marketed Abilify.
The U.S. Department of Justice accused Bristol-Myers Squibb of promoting Abilify for pediatric use and to treat dementia-related psychosis. Neither of these uses was FDA-approved.
Children, Dementia Patients Targeted
Bristol-Myers Squibb directed its “sales force to call on child psychiatrists and other pediatric specialists, and the sales force then urged physicians and others providers to prescribe Abilify for pediatric patients,” the Department of Justice said in a statement.
The company also created a specialized long-term care sales team that “called almost exclusively on nursing homes, where dementia-related psychosis is far more prevalent than schizophrenia or bipolar disorder.”
The settlement included more than $25 million in profits made from marketing Abilify for the unapproved uses.
The U.S. Department of Justice joined seven whistleblower lawsuits. The whistleblowers who filed the complaints stand to get about $50 million of the settlement.
States, D.C. Reach $19.5M Deal
In December 2016, Bristol-Myers Squibb agreed to pay a $19.5 million settlement to 43 states and the District of Columbia.
State governments claimed the company engaged in unfair or deceptive trade practices when marketing Abilify. The case involved the same practices alleged in the 2007 federal suit.
Bristol-Myers Squibb denied any wrongdoing, saying it settled so it could move on with its mission of developing “making transformational medicines for patients battling serious diseases.”
Please seek the advice of a medical professional before making health care decisions.